St. Jude Medical Announces FDA Approval of New ICD Software for the Merlin(TM) Patient Care System.Software Provides Fast and Simple Programming of ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. Devices ST. PAUL, Minn. -- St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE See: New York Stock Exchange :STJ STJ Superior Tribunal de Justica (Brazil) STJ Supremo Tribunal de Justiça (Portugal) STJ Superconducting Tunnel Junction STJ San Giljan (postal locality, Malta) ) today announced U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval of its new tachycardia tachycardia: see arrhythmia. tachycardia Heart rate over 100 (as high as 240) beats per minute. When it is a normal response to exercise or stress, it is no danger to healthy people, but when it originates elsewhere, it is an arrhythmia. software for the Merlin([TM]) Patient Care System, a state-of-the-art computer used to program and interrogate cardiac rhythm management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. devices like pacemakers and implantable cardioverter defibrillators (ICDs). This software upgrade, which will be launched over the coming weeks, extends the benefits of the previously released Merlin graphical user interface graphical user interface (GUI) Computer display format that allows the user to select commands, call up files, start programs, and do other routine tasks by using a mouse to point to pictorial symbols (icons) or lists of menu choices on the screen as opposed to having to to both St. Jude Medical pacemaker and ICD products. The system, which supports current and previous generation devices, is one of more than 20 new cardiac rhythm management products being introduced by St. Jude Medical this year. The Merlin Patient Care System, which received FDA approval in April 2006, is a programmer designed to help physicians more efficiently conduct tests and analyze therapeutic and diagnostic data. This powerful, portable computer helps physicians retrieve and analyze patient information during routine pacemaker and ICD follow-up visits, providing quality patient care. With the Merlin Patient Care System, physicians can quickly and easily make changes to device therapy using an LCD touch-screen. The system's streamlined workflow is designed to increase productivity for physicians and clinic staff. With the Merlin Patient Care System, patients can receive the same high standard of care during follow-up visits that take significantly less time. "The Merlin system has truly raised the bar in helping me provide better care to my patients," said Joseph Dell'Orfano, M.D., Saint Francis Hospital and Medical Center, Hartford, Conn. "This new ICD software allows me to increase the efficiency of my clinic by reducing patient follow-up time and simplifying training requirements for my staff." The Merlin Patient Care System was designed with the help of clinicians to better manage patients with pacemakers and ICDs. The system represents an evolution in programmer technology and includes easy-to-use graphical screens so clinicians can more efficiently assess device function and care for their patients. With the new software, this system provides physicians with a complete solution to St. Jude Medical pacemaker and ICD follow-up visits. "Physicians have responded enthusiastically to the Merlin Patient Care System," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "With the new ICD interface, we are demonstrating our commitment to making follow-ups more efficient for both our bradycardia bradycardia: see arrhythmia. and tachycardia customers, while focusing on patients." About St. Jude Medical St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. , cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 11,000 people worldwide. For more information, please visit www.sjm.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, regulatory approvals, anticipated future product launches, revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Report on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page 32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance. |
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